A Study to Investigate the Effect of Food on the Absorption, Distribution and Elimination of ASP1941

Astellas

Status and phase

Completed

Phase 1

Conditions

Pharmacokinetics of ASP1941

Healthy

Treatments

Drug: ASP1941

Study type

Interventional

Funder types

Industry

Identifiers

NCT01674777

1941-CL-0071

Details and patient eligibility

About

This study is to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects.

Full description

This will be a randomized, open-label, 3-way crossover design study to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects. Each subject will receive a single dose of ASP1941 "under fasting condition", "before meal" and "after meal".

Enrollment

30 patients

Sex

Male

Ages

20 to 44 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and laboratory tests
Body weight ; ≥50.0 kg, <80.0 kg
Body Mass Index ; ≥17.6, <26.4
Written informed consent has been obtained

Exclusion criteria

Received any investigational drugs within 120 days before the screening assessment
Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or d components within 14 days before the screening assessment
Received medication within 7 days before hospital admission
A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission
History of drug allergies
With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases